Cleared Traditional

K992484 - RCNG: ROOT CANAL NEGOTIATING GEL

Also marketed or referenced as:

MODEL RCNG

K992484 · Jordco, Inc. · Dental device

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Oct 1999

Decision

80d

Days

Risk

K992484 is an FDA 510(k) clearance for the RCNG: ROOT CANAL NEGOTIATING GEL. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Jordco, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jordco, Inc. devices

FDA 510(k) Submission Details - K992484

510(k) Number	K992484 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 26, 1999
Decision Date	October 14, 1999
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

47d faster than avg

Panel avg: 127d · This submission: 80d

Pathway characteristics

Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code	KJJ Cleanser, Root Canal
Device Class	-

Regulatory Peers - KJJ Cleanser, Root Canal

All 26

Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K992484.

ULTRADENT CITRIC ACID 10% SOLUTION

K032627 · Ultradent Products, Inc. · Nov 2003

SMEARCLEAR

K024198 · Sybron Dental Specialties, Inc. · Mar 2003

OXY-GLIDE ROOT CANAL CLEANSER & LUB.

K992919 · Super Glide, Inc. · Nov 1999

PULPDENT SODIUM HYPOCHLORITE SOLUTION

K962743 · Pulpdent Corp. · Aug 1996

FILE-EZE

K934415 · Ultradent Products, Inc. · Apr 1994

CLEANSER, ROOT CANAL

K802853 · Dentsply Intl. · Dec 1980

FDA 510(k) Resources - Dental

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K992484

Jordco, Inc.

Beaverton, OR · US

HAL J OIEN

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in Dental

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: October 14, 1999. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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